BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY DIAGNOSTIC CATHETER

    MDR report key: 1207926 · Received October 14, 2008

    Report

    Report Number
    2030404-2008-00014
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    IRVINE BIOMEDICAL, INC (IBI), A ST JUDE MEDICAL COMPANY
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT CONSEQUENCE WAS REPORTED. ONE RETURNED CATHETER WAS RECEIVED ON 10/01/2008. THE UNIT WAS VISUALLY EXAMINED AND THE COMPLAINT DESCRIPTION WAS CONFIRMED. THE INVESTIGATION IS AS FOLLOWS: UPON VISUAL INSPECTION, THE RETURNED CATHETER WAS FOUND DAMAGED 12.8 CM FROM THE DISTAL TIP. ELECTRICAL FUNCTIONALITY TESTING WAS CONDUCTED ON THE RETURNED CATHETER. THE CATHETER MET SPECIFICATIONS. THE CATHETER ALSO MET CURVE TEMPLATE REQUIREMENTS. THE DEVICE HISTORY RECORD FOR LOT NUMBER 57275 WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WERE PERFORMED AND REPORTED AS COMPLETE AND ACCEPTABLE. NO EVIDENCE OF A MANUFACTURING ERROR COULD BE FOUND. INCOMING INSPECTION RECORDS OF THE TUBING LOT RECEIVED FROM THE VENDOR WERE REVIEWED AND NO ABNORMALITIES WERE FOUND. ALL CATHETERS ARE 100% INSPECTED IN-PROCESS AND AT FINAL INSPECTION FOR ELECTRICAL AND MECHANICAL INTEGRITY TO ENSURE THEY MET THE SPECIFICATION REQUIREMENTS. THE 2007 AND 2008 COMPLAINTS WERE REVIEWED. THIS IS A RARE OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SHAFT WAS DAMAGED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INQUIRY DIAGNOSTIC CATHETER ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER DQO IRVINE BIOMEDICAL, INC (IBI), A ST JUDE MEDICAL COMPANY 80405 57275

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK